BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSTIE

    MDR report key: 15502064 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00023
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    April 20, 2018
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HWC
    UDI-DI
    00815432022045
    PMA / PMN Number
    K151270
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING LHR'S WERE REVIEWED AND NO EVIDENCE WAS FOUND TO SUGGEST THE DEVICES DID NOT MEET SPECIFICATIONS. PART NUMBER LOT NUMBER 1443-2501 102861 100059 102827 THE FAILURE MODE WAS NOT RECREATED IN A CADAVER LAB WITH A FIRST-TIME USER. HOWEVER, WITH INTENTION AND DIFFICULTY, THE FAILURE MODE WAS SUCCESSFULLY RECREATED. THE PREVIOUS INVESTIGATIONS SUGGEST THAT THE FAILURE OCCURS WHEN A SLIP OCCURS DUE TO THE INSTABLE PROXIMAL PHALANX AND A RESULTING TORQUE IS PLACED ON THE IMPLANT. THIS TORQUE IS SIGNIFICANT ENOUGH TO BREAK THE IMPLANT IF THE INSERTION FORCE IS BEING APPLIED TO THE DISTAL END OF THE INSERTER. THE FORCE REQUIRED TO FULLY INSERT THE IMPLANT IS REDUCED WHEN A 2.5 MM REAMER IS USED. AFTER USE WITH A 2.5MM REAMER, THE IMPLANT WAS STILL SECURELY HELD IN PLACE BY A TIGHT FIT DURING THE CADAVER LAB. NO COMPLAINTS HAVE BEEN OPENED REGARDING CROSSTIE IMPLANTS THAT DID NOT PERFORM AS INTENDED AFTER IMPLEMENTATION WHEN A 2.5MM REAMER WAS USED. HOWEVER, A 2.2MM REAMER MAY STILL BE USED, ESPECIALLY IN THE CASES OF POOR/SOFT BONE QUALITY.

    Description of Event or Problem · 0

    A CROSSTIE IMPLANT FRACTURED DURING INSERTION. THE IMPLANT WAS BEING INSERTED WITH A UNIVERSAL INSERTER AND THE HOLE WAS REAMED WITH A 2.2 REAMER. THE PATIENT HAD SLIGHTLY POOR/SOFT BONE QUALITY. THERE WAS NO HARM TO THE PATIENT. THE IMPLANT WAS REMOVED AND ANOTHER 2.5MM IMPLANT WAS SUCCESSFULLY INSERTED. THE INCIDENT RESULTED IN AN ESTIMATED 5-MINUTE DELAY IN SURGERY AND DOCTOR WAS PLEASED WITH THE OUTCOME AND DID NOT HAVE ANY NEGATIVE COMMENTS REGARDING THE BROKEN IMPLANT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS SUCCESSFULLY INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2934877 CROSSTIE SCREW, FIXATION, BONE HWC CROSSROADS EXTREMITY SYSTEMS 1443-2501 102861 00815432022045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other